Clearance Summary
GLUSEAL 90, MODEL GLU9010 received FDA 510(k) clearance under submission number K083752, sponsored by Glustitch, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-02-23.
- Submission: K083752
- Applicant / Sponsor: Glustitch, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 2009-02-23
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.